技术领域technical field
本发明属于医疗电子仪器技术领域,特别是涉及一种通过植入体内自动感知、自动启动、通过程序化多点顺序电刺激促进消化道运动正常化、治疗上消化道动力障碍性疾病的治疗装置。The invention belongs to the technical field of medical electronic instruments, and in particular relates to a therapeutic device for automatically sensing and automatically starting by implanting in the body, promoting the normalization of digestive tract movement through programmed multi-point sequential electrical stimulation, and treating upper digestive tract motility disorders .
背景技术Background technique
消化道动力障碍性疾病是消化系常见的一类疾病,常见的有消化道动力障碍性疾病、胃消化道反流病、胃轻瘫等。目前缺乏有效的药物治疗。直接电刺激消化道平滑肌细胞可以产生收缩效应。理论上,电刺激也可影响乃至控制消化道运动。但目前,电刺激在消化道疾病中的应用还比较初步:电刺激(频率:5. 5 cpm ,波宽:550 ms ,波幅:2 mA)大鼠胃浆膜面可纠正胃电节律紊乱促进胃排空[刘劲松, 乔娴, 侯晓华,等. 胃电起搏对糖尿病胃轻瘫大鼠胃电节律异常和胃排空延迟的治疗作用. 中华消化杂志. 2004(24)10:615-616.];多点电刺激(50 Hz rectangular voltage having 20 V(peak to peak) amplitude, 18 second stimulus duration, and a nine second phase lag between stimulation trains in sequential electrode sets.)犬离体结肠肠管可促进其蠕动[M A Amaris, P Z Rashev, M P Mintchev, et al. Microprocessor controlled movement of solid colonic content using sequential neural electrical stimulation. Gut 2002;50:475–479]。Gastrointestinal motility disorders are common diseases of the digestive system, such as gastrointestinal motility disorders, gastro-digestive reflux disease, and gastroparesis. There is currently a lack of effective drug treatments. Direct electrical stimulation of smooth muscle cells of the digestive tract can produce a contractile effect. Theoretically, electrical stimulation can also affect or even control the motility of the digestive tract. But at present, the application of electrical stimulation in digestive tract diseases is still relatively preliminary: electrical stimulation (frequency: 5.5 cpm, wave width: 550 ms, amplitude: 2 mA) on the gastric serosal surface of rats can correct gastric electrical rhythm disorder and promote Gastric emptying[Liu Jinsong, Qiao Xian, Hou Xiaohua, et al. The therapeutic effect of gastric electrical pacing on abnormal gastric electrical rhythm and delayed gastric emptying in diabetic gastroparesis rats. Chinese Journal of Digestion. 2004(24)10:615-616 .]; Multi-point electrical stimulation (50 Hz rectangular voltage having 20 V(peak to peak) amplitude, 18 second stimulus duration, and a nine second phase lag between stimulation trains in sequential electrode sets.) Canine isolated colon intestine can promote its Peristalsis [M A Amaris, P Z Rashev, M P Mintchev, et al. Microprocessor controlled movement of solid colonic content using sequential neural electrical stimulation. Gut 2002;50:475–479].
尽管这方面的相应研究比较少,但都表明通过电刺激治疗消化道动力障碍性疾病是可行的。现在国内外并无此类仪器应用于临床。Although there are relatively few corresponding studies in this area, they all show that it is feasible to treat digestive tract motility disorders through electrical stimulation. There is no such instrument used clinically both at home and abroad.
发明内容Contents of the invention
本发明的目的是开发一种植入体内自动感知、自动启动、通过程序化多点顺序电刺激促进上消化道运动正常化的黏膜下植入电极自动感知消化道顺序起搏治疗仪。The purpose of the present invention is to develop a submucosal implanted electrode automatic sensing digestive tract sequential pacing therapy device implanted in the body to automatically sense, automatically start, and promote the normalization of upper gastrointestinal motility through programmed multi-point sequential electrical stimulation.
本发明为解决这一问题所采取的技术方案是:The technical scheme that the present invention takes for solving this problem is:
本发明的黏膜下植入电极自动感知消化道顺序起搏治疗仪,包括一植入系统控制器,多个用于检测消化道活动的传感器,多个植入式电极和体外系统控制器;植入系统控制器的输入信号端与可检测消化道活动的传感器连接;植入系统控制器的输出信号端与植入式电极连接。The submucosal implanted electrode of the present invention automatically senses the sequential pacing of the digestive tract, including an implanted system controller, a plurality of sensors for detecting the activity of the digestive tract, a plurality of implanted electrodes and an in vitro system controller; The input signal end of the implant system controller is connected with the sensor capable of detecting digestive tract activity; the output signal end of the implant system controller is connected with the implanted electrode.
所述的传感器中的一个是胃肠系统内pH值变化传感器。一个是胃肠系统内电势值变化传感器;一个是胃肠系统内压强变化传感器;一个是胃肠系统内温度变化传感器;一个是胃肠系统内体积变化传感器。One of the sensors is a pH change sensor in the gastrointestinal system. One is a potential value change sensor in the gastrointestinal system; the other is a pressure change sensor in the gastrointestinal system; the other is a temperature change sensor in the gastrointestinal system; the other is a volume change sensor in the gastrointestinal system.
所述的植入系统控制器包括一个内部中央处理器、一个内部存储器,一个事件检测器,以及一个或多个信号发生器;这些信号发生器向一个或多个植入式电极输出多组刺激信号用于刺激每个植入式电极周围的肌肉完成收缩活动;事件检测器用于接收多个传感器所输入的一组或多组信号,并通过分析这一组或多组信号来识别出消化道的一个特定的状态;内部中央处理器接收由事件检测器输入的代表一个特定的消化道活动的信号,储存这个信号至内部存储器中,控制由信号发生器所释放许多组的刺激信号之间的时间间隔,从而协调每个植入式电极周围的肌肉收缩活动的时间顺序。The implanted system controller includes an internal central processing unit, an internal memory, an event detector, and one or more signal generators; these signal generators output multiple sets of stimulation to one or more implanted electrodes The signal is used to stimulate the muscles around each implanted electrode to complete the contraction activity; the event detector is used to receive one or more sets of signals input from multiple sensors and analyze the set or sets of signals to identify the digestive tract A specific state; the internal central processing unit receives the signal representing a specific digestive tract activity input by the event detector, stores this signal in the internal memory, and controls the stimulation signal released by the signal generator in many groups. time intervals, thereby coordinating the temporal sequence of muscle contraction activity around each implanted electrode.
所述的植入系统控制器还包括一个内部通讯器,内部通讯器通过无线方式将患者消化道状态、植入系统控制器工作过程、植入系统控制器工作程序信息传输给体外系统控制器,并接收体外系统控制器发送给植入系统控制器程序调控指令。The implanted system controller also includes an internal communicator, which transmits the status of the patient's digestive tract, the working process of the implanted system controller, and the working program of the implanted system controller to the external system controller through wireless means. And receive program control instructions sent by the in vitro system controller to the implanted system controller.
所述的植入系统控制器还包括一个启动/关闭按钮,这一个启动/关闭按钮被患者触发时,启动或关闭系统控制器、传感器和植入式电极,以应对突发事件。The implanted system controller also includes an on/off button. When the on/off button is triggered by the patient, the system controller, sensors and implanted electrodes are activated or shut down to deal with emergencies.
所述的体外系统控制器一个体外中央处理器,一个体外存储器和一个体外通讯器;体外通讯器应用无线工作方式实现体外系统控制器与植入系统控制器的信息交流;体外中央处理器通过由内部通讯器和体外通讯器组成的通讯途径实现对植入系统控制器的调控和信息交流,储存这些信息至体外存储器,并完成这些信息的显示和输出。The in vitro system controller has an in vitro central processing unit, an in vitro memory and an in vitro communicator; the in vitro communicator uses a wireless working mode to realize the information exchange between the in vitro system controller and the implanted system controller; The communication path composed of the internal communicator and the external communicator realizes the control and information exchange of the implanted system controller, stores the information to the external memory, and completes the display and output of the information.
每个植入式电极包括蜈蚣电极,一个套管和一个电极释放后将电极固定在食管固有肌层上的电极末端的固定装置;蜈蚣电极被束缚在套管内;每对对应的蜈蚣电极将按固定间隔固定缠绕成一条线缆,每对蜈蚣电极释放时可环绕食管腔半周,形成独特的电流刺激环路,引起食管环形肌收缩。Each implantable electrode consists of a centipede electrode, a cannula, and a fixation device for the electrode end that fixes the electrode to the muscularis propria of the esophagus after the electrode is released; the centipede electrodes are bound within the cannula; each pair of corresponding centipede electrodes will press Fixed intervals are fixed and wound into a cable, and each pair of centipede electrodes can surround the esophageal lumen for half a circle when released, forming a unique current stimulation loop, causing the contraction of the esophageal circular muscle.
本发明具有的优点和积极效果是:The advantages and positive effects that the present invention has are:
本发明的治疗仪可以接收多个传感器所输入的一组或多组信号,并通过植入系统控制器分析这一组或多组信号来识别出消化道的一个特定的状态。然后,植入系统控制器通过一个或多个信号发生器可向一个或多个植入式电极输出许多组刺激信号用于刺激每个植入式电极周围的肌肉完成收缩活动。The therapeutic apparatus of the present invention can receive one or more sets of signals input by multiple sensors, and analyze the one or more sets of signals through the implanted system controller to identify a specific state of the digestive tract. Then, the implanted system controller can output many groups of stimulation signals to one or more implanted electrodes through one or more signal generators to stimulate the muscles around each implanted electrode to complete the contraction activity.
本发明具有以下的优点:第一,根据不同疾病及消化道不同部位的解剖和生理特点选择不同的传感器以及不同的传感器和电极的植入方式、植入位置和固定方式;第二,传感器将实时的消化道状态转化为电信号,并对电信号进行调理,转换成数字信号进行存储,并传输给植入系统控制器;第三,植入系统控制器是该装置的控制核心,传感器数据采集、存储和传输都由植入系统控制器完成,刺激信号也有植入系统控制器产生;第四,体外控制器可以通过通讯器接收植入系统控制器内存储的数据,并对数据进行整理分析,通过人机交互方式生成报告,并且可以调整植入系统控制器程序,从而达到最佳的治疗效果;第五,本发明的黏膜下植入电极自动感知消化道顺序起搏治疗仪可以长期植入患者体内,根据患者消化道运动状态自动产生一组或多组顺序刺激信号,刺激消化道恢复正常生理状态。The present invention has the following advantages: first, different sensors and implantation methods, implantation positions and fixing methods of different sensors and electrodes are selected according to the anatomy and physiological characteristics of different diseases and different parts of the digestive tract; The real-time digestive tract status is converted into electrical signals, and the electrical signals are conditioned, converted into digital signals for storage, and transmitted to the implant system controller; thirdly, the implant system controller is the control core of the device, and the sensor data Acquisition, storage and transmission are all completed by the implanted system controller, and the stimulation signal is also generated by the implanted system controller; fourth, the external controller can receive the data stored in the implanted system controller through the communicator, and organize the data Analysis, generating reports through human-computer interaction, and can adjust the implanted system controller program, so as to achieve the best therapeutic effect; Implanted into the patient's body, one or more sets of sequential stimulation signals are automatically generated according to the movement state of the patient's digestive tract to stimulate the digestive tract to return to its normal physiological state.
附图说明Description of drawings
图1是本发明的治疗仪的总体结构框架图;Fig. 1 is the overall structural frame diagram of therapeutic apparatus of the present invention;
图2是本发明的治疗仪的一个应用实例图;Fig. 2 is an application example figure of therapeutic apparatus of the present invention;
图3是本发明的植入式电极的结构示意图。Fig. 3 is a schematic structural view of the implantable electrode of the present invention.
附图中主要部件符号说明:Explanation of symbols of main components in the accompanying drawings:
1:植入系统控制器 2:传感器1: implanted system controller 2: sensor
3:植入式电极 4:体外系统控制器3: Implantable electrodes 4: In vitro system controller
101:事件检测器 102:信号发生器101: Event detector 102: Signal generator
103:内部存储器 104:内部中央处理器103: Internal memory 104: Internal CPU
105:内部通讯器 106:启动/关闭按钮105: Intercommunicator 106: On/off button
301:蜈蚣电极 302:套管301: Centipede electrode 302: Sleeve
303:固定装置 403:体外存储器303: Fixtures 403: Extracorporeal memory
404:体外中央处理器 405:体外通讯器。404: External central processing unit 405: External communicator.
具体实施方式Detailed ways
以下参照附图及实施例对本发明进行详细的说明。The present invention will be described in detail below with reference to the drawings and examples.
本发明的黏膜下植入电极自动感知消化道顺序起搏治疗仪包括一植入系统控制器1,多个用于检测消化道活动的传感器2,多个植入式电极3和体外系统控制器4。本发明的治疗仪可以长期植入患者体内,根据患者消化道运动状态自动产生一组或多组顺序刺激信号,刺激消化道恢复正常生理状态。其中:The submucosal implanted electrode of the present invention automatically senses the sequential pacing of the digestive tract, including an implanted system controller 1, a plurality of sensors 2 for detecting the activity of the digestive tract, a plurality of implanted electrodes 3 and an external system controller 4. The therapeutic apparatus of the present invention can be implanted in the patient's body for a long time, automatically generates one or more sets of sequential stimulation signals according to the movement state of the patient's digestive tract, and stimulates the digestive tract to restore the normal physiological state. in:
植入系统控制器 1的输入信号端连接到多个可检测消化道活动的传感器2;植入系统控制器 1的输出信号端连接到多个植入式电极3;The input signal end of the implant system controller 1 is connected to a plurality of sensors 2 capable of detecting digestive tract activities; the output signal end of the implant system controller 1 is connected to a plurality of implantable electrodes 3;
传感器2可以植入消化道并以一种形式将传感器2与消化道固定,适用于检测一种或多种发生在胃肠系统内的活动。胃肠系统包含形成消化道和胃的器官组织和由形成消化道和胃的器官组织所形成的内腔。传感器2与消化道固定的形成包括:将传感器固定在消化道黏膜层表面;将传感器固定在消化道浆膜层表面;将传感器固定在消化道浆膜层与黏膜层之间的任何一层;将传感器固定在消化道浆膜层与黏膜层之间的任何两层之间。实际操作中可以根据不同的需要选择不同的固定形式。传感器2中的一个是适用于检测胃肠系统内pH值变化的传感器。一个是适用于检测胃肠系统内电势值变化的传感器;一个是适用于检测胃肠系统内压强变化的传感器;一个是适用于检测胃肠系统内温度变化的传感器;一个是适用于检测胃肠系统内体积变化的传感器。The sensor 2 can be implanted in the alimentary canal and fixed to the alimentary canal in a form suitable for detecting one or more activities occurring in the gastrointestinal system. The gastrointestinal system consists of the organ tissues forming the digestive tract and stomach and the lumen formed by the organ tissues forming the digestive tract and stomach. The formation of the sensor 2 and the digestive tract fixation includes: fixing the sensor on the surface of the digestive tract mucosal layer; fixing the sensor on the surface of the digestive tract serosal layer; fixing the sensor on any layer between the digestive tract serosa layer and the mucosal layer; Immobilize the sensor between any two layers of the alimentary canal between the serosa and the mucosa. In actual operation, different fixing forms can be selected according to different needs. One of the sensors 2 is a sensor adapted to detect pH changes in the gastrointestinal system. One is a sensor suitable for detecting changes in the potential value in the gastrointestinal system; the other is a sensor suitable for detecting pressure changes in the gastrointestinal system; one is a sensor suitable for detecting temperature changes in the gastrointestinal system; the other is suitable for detecting changes in the gastrointestinal system. A sensor for volume changes within the system.
植入系统控制器1包括一个事件检测器101,这一个事件检测器101可以接收多个传感器2所输入的一组或多组信号,并通过分析这一组或多组信号来识别出消化道的一个特定的状态并存储于存储器103。The implant system controller 1 includes an event detector 101, which can receive one or more sets of signals input by multiple sensors 2, and identify the digestive tract by analyzing the one or more sets of signals. A specific state of the system is stored in the memory 103.
植入系统控制器1还包括一个或多个信号发生器102,这一个或多个信号发生器102可向一个或多个植入式电极3输出许多组刺激信号用于刺激每个植入式电极3周围的肌肉完成收缩活动。The implant system controller 1 also includes one or more signal generators 102, which can output many sets of stimulation signals to one or more implant electrodes 3 for stimulating each implant electrode. The muscles around the electrode 3 complete the contraction activity.
植入系统控制器1还包括一个内部存储器103,用于存储消化道状态和输出信号的数据。Implantation system controller 1 also includes an internal memory 103 for storing the data of the digestive tract status and output signals.
植入系统控制器1还包括一个内部中央处理器104,这一个内部中央处理器104可接收由事件检测器101输入的代表一个特定的消化道活动的信号,储存这个信号至内部存储器103,控制由信号发生器102所释放的多组刺激信号之间的时间间隔,从而协调每个植入式电极3周围的肌肉收缩活动的时间顺序。The implant system controller 1 also includes an internal central processing unit 104. This internal central processing unit 104 can receive a signal representing a specific digestive tract activity input by the event detector 101, store this signal in the internal memory 103, and control The time interval between multiple sets of stimulation signals released by the signal generator 102 coordinates the time sequence of muscle contraction activities around each implanted electrode 3 .
消化道的一个特定的状态是指消化道内存在残留积食的状态。每当植入系统控制器1识别出一个特定的消化道活动,即向至少一个植入式电极3释放至少一组的刺激信号从而达到控制至少一个植入式电极3周围的肌肉收缩或舒张活动。A specific state of the digestive tract refers to the state of residual food accumulation in the digestive tract. Whenever the implanted system controller 1 recognizes a specific digestive tract activity, it releases at least one set of stimulation signals to at least one implanted electrode 3 so as to control the muscle contraction or relaxation around the at least one implanted electrode 3 .
当植入系统控制器1无法识别出一个特定的消化道活动,即停止向所有植入式电极3释放刺激信号从而达到停止刺激所有植入式电极3周围的肌肉收缩活动。When the implanted system controller 1 cannot recognize a specific digestive tract activity, it stops releasing stimulation signals to all implanted electrodes 3 so as to stop stimulating the muscle contraction activities around all implanted electrodes 3 .
植入系统控制器1还包括一个内部通讯器105,这一个内部通讯器105可以通过无线方式将患者消化道状态、植入系统控制器1工作过程、植入系统控制器1工作程序等信息传输给体外系统控制器4,并可以接收体外系统控制器4发送给系统控制器1程序调控指令。The implanted system controller 1 also includes an internal communicator 105, which can wirelessly transmit information such as the status of the patient's digestive tract, the working process of the implanted system controller 1, and the working program of the implanted system controller 1. to the in vitro system controller 4, and can receive program control instructions sent by the in vitro system controller 4 to the system controller 1.
植入系统控制器1也包括一个启动/关闭按钮106,这一个启动/关闭按钮106被患者触发时,可以启动或关闭植入系统控制器1、传感器2和植入式电极3,用以应对突发事件。The implant system controller 1 also includes an on/off button 106. When the on/off button 106 is triggered by the patient, the implant system controller 1, the sensor 2 and the implanted electrode 3 can be turned on or off to deal with Emergencies.
植入式电极3可通过胃镜引导留置于通过胃镜在上消化道黏膜下层建立的隧道内。植入式电极3包括成对设置的蜈蚣电极301,每对对应电极将按固定间隔固定缠绕成一条线缆,每对电极释放时可环绕食管腔约半周,形成独特的电流刺激环路,引起食管环形肌收缩。The implantable electrode 3 can be left in the tunnel established in the upper gastrointestinal submucosa through the gastroscope under the guidance of the gastroscope. The implantable electrode 3 includes centipede electrodes 301 arranged in pairs, and each pair of corresponding electrodes will be fixedly wound into a cable at a fixed interval, and each pair of electrodes can surround the esophageal lumen for about half a circle when released, forming a unique current stimulation loop, Causes contraction of the circular muscle of the esophagus.
植入式电极3包括一个套管302,在蜈蚣电极301放置前将电极束缚在套管内,当放置到理想位置时可将导管退出,蜈蚣电极301可自行释放成功能状态。植入式电极3也包括一个电极末端的固定装置303可将电极固定在食管固有肌层。The implantable electrode 3 includes a cannula 302. Before the centipede electrode 301 is placed, the electrode is bound in the cannula. When the centipede electrode 301 is placed in an ideal position, the catheter can be withdrawn, and the centipede electrode 301 can be released into a functional state by itself. The implantable electrode 3 also includes a fixing device 303 at the end of the electrode to fix the electrode on the muscularis propria of the esophagus.
体外系统控制器4包括一个体外存储器403,一个体外通讯器405,这一个体外通讯器405可以应用无线工作方式实现体外系统控制器4与系统控制器1的信息交流。The extracorporeal system controller 4 includes an extracorporeal memory 403 and an extracorporeal communicator 405. The extracorporeal communicator 405 can realize the information exchange between the extracorporeal system controller 4 and the system controller 1 in a wireless working mode.
体外系统控制器4也包括一个中央处理器404,这一个中央处理器404用于通过由内部通讯器105和体外通讯器405组成的通讯途径实现对植入系统控制器1的调控和信息交流,储存这些信息至体外存储器403,并可实现这些信息的显示和输出功能。The extracorporeal system controller 4 also includes a central processing unit 404, which is used to realize the control and information exchange of the implanted system controller 1 through the communication path composed of the internal communicator 105 and the extracorporeal communicator 405, These information are stored in the external memory 403, and the display and output functions of these information can be realized.
使用本发明的黏膜下植入电极自动感知消化道顺序起搏治疗仪治疗消化道动力障碍性疾病的方法的方法及本发明的工作过程如下:The method of using the submucosal implanted electrode of the present invention to automatically sense the digestive tract sequential pacing therapeutic instrument to treat digestive tract motility disorders and the working process of the present invention are as follows:
经內镜在上消化道黏膜下层建立隧道,在內镜引导下将植入式电极固定在隧道腔内,并释放蜈蚣电极,蜈蚣电极的末端与植入皮下的系统控制器联接。A tunnel is established in the submucosal layer of the upper gastrointestinal tract through the endoscope, and the implanted electrode is fixed in the tunnel cavity under the guidance of the endoscope, and the centipede electrode is released. The end of the centipede electrode is connected to the system controller implanted subcutaneously.
由传感器持续检测一组或多组可代表病人的消化道的活动的信号; One or more sets of signals representative of the activity of the patient's digestive tract are continuously detected by the sensor;
由系统控制器持续分析并识别出病人的消化道内是否存在残留积食; The system controller continuously analyzes and identifies whether there is residual food in the patient's digestive tract;
当系统控制器识别出病人的消化道内存在积食时,系统控制器向一组或多组电极释放刺激信号,这些信号拥有一定的时序特征,当其按照此时序特征刺激被植入消化道不同部位的电极时,电极周围的肌肉可以有规律的收缩以使消化道内残留的积食被向下推压入胃腔内;When the system controller recognizes food accumulation in the patient's digestive tract, the system controller releases stimulation signals to one or more groups of electrodes. These signals have certain timing characteristics. When they are implanted in different parts of the digestive tract according to the timing characteristics When using the electrode, the muscles around the electrode can contract regularly so that the residual food in the digestive tract is pushed down into the gastric cavity;
当系统控制器识别出病人的消化道内不存在积食时,系统控制器停止向所有电极释放刺激信号。When the system controller recognizes that there is no food accumulation in the patient's digestive tract, the system controller stops releasing stimulation signals to all electrodes.
当出现特殊情况可由病人临时释放刺激信号。When a special situation occurs, the patient can temporarily release the stimulation signal.
当出现紧急情况可由病人紧急关闭系统控制器、传感器和植入电极。When an emergency occurs, the system controller, sensors and implanted electrodes can be shut down urgently by the patient.
医生可读取并存储患者信息,并根据患者个体特点调整系统控制器程序。Doctors can read and store patient information, and adjust the system controller program according to individual patient characteristics.
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CN201310053465.9ACN103143116B (en) | 2013-02-20 | 2013-02-20 | Implant electrode automatic sensing digestive tract order pacing therapy instrument under mucosa |
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CN201310053465.9ACN103143116B (en) | 2013-02-20 | 2013-02-20 | Implant electrode automatic sensing digestive tract order pacing therapy instrument under mucosa |
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CN201310053465.9AActiveCN103143116B (en) | 2013-02-20 | 2013-02-20 | Implant electrode automatic sensing digestive tract order pacing therapy instrument under mucosa |
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